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Completed

NCT Number: NCT01783327

Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes

The purpose of this study is to evaluate the use of a state-of the art internet psycho-educational program in clinical practice (Teens-Connect), compared to use of a standard and widely available internet diabetes program for youth (Planet D™) in a mixed-method randomized clinical trial design.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Nursing, New Haven, Connecticut, United States

Loading trial locations.

About this study

The aims are:

  • To evaluate the efficacy and cost-effectiveness of provider-prescribed Teens-Connect (TEENCOPE™+Managing Diabetes) in pediatric diabetes practice compared to prescription of Planet D™.

The hypotheses to be studied are:

  • Youth who participate in Teens-Connect will have better metabolic control (A1c) and quality of life (QOL) than those who participate in Planet D.
  • These effects will be mediated by improvements in stress/coping, self-efficacy, diabetes problem-solving, and self-management.
  • Teens-Connect prescribed by providers in diabetes clinics will be a cost-effective approach to reduce A1c and improve quality-adjusted life years (QALYs) for youth with T1D.
  • To compare the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the two provider-prescribed psycho-educational internet programs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with type 1 diabetes for at least 6 months
  • Age 11 to 14 years
  • English-speaking
  • Assent
  • Parent/guardian consent to participate in study

Exclusion criteria

*Previous exposure to TEENCOPE and/or Managing Diabetes

Treatment and study plan

Teens-Connect

Behavioral

Teens-Connect combines Managing Diabetes and TEENCOPE. Managing Diabetes consists of 5 sessions on age-appropriate, educational content related to diabetes problem-solving and self-efficacy to improve self-management. TEENCOPE consists of 5 sessions designed to increase youth's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. The program is highly interactive and youth can talk with each other on an online moderated discussion board. Youth will be asked to use the website at least twice per week for 4 weeks.

Planet D

Behavioral

Planet D provides age-appropriate diabetes education on a variety of topics and social networking discussion boards on diabetes, food and exercise, personal interests, and diabetes camp. Planet D addresses emotions and self-management through education and social networking. Youth who register can also create a profile, upload and share pictures, identify favorite news and blog feeds as well as provide comments or tags to other members. Planet D has been online since 2007 and contains numerous diabetes-related articles geared toward youth as well as a secure message board. Youth will be asked to interact with the website twice a week for 4 weeks.

Primary outcomes

  1. Change from baseline hemoglobin A1c over 12 months

    Time frame: Baseline, 6 weeks, 6 months, 12 months

  2. Change from baseline quality of life over 12 months

    Time frame: Baseline, 6 weeks, 6 months, 12 months

Secondary outcomes

  1. Change from baseline coping/Stress over 12 months

    Time frame: Baseline, 6 weeks, 6 months, 12 months

    Coping/stress will be measured using the Perceived Stress Scale

  2. Change from baseline self-efficacy over 12 months

    Time frame: Baseline, 6 weeks, 6 months, 12 months

    Self-efficacy will be assessed using the Self-efficacy for Diabetes Scale

  3. Change from baseline problem-solving over 12 months

    Time frame: Baseline, 6 weeks, 6 months, 12 months

    Problem-solving will be assessed using the Self-Management of Diabetes-Adolescent (SMOD-A) questionnaire

  4. Change from baseline self-management over 12 months

    Time frame: Baseline, 6 weeks, 6 months, 12 months

    Self-management will be assessed using the Self-care Inventory (SCI)

  5. Costs

    Time frame: 6 months

    Costs will be assessed using financial and staff records

  6. Change from baseline quality adjusted life years over 12 months

    Time frame: Baseline, 6 weeks, 6 months, 12 months

    Quality adjusted life years will be assessed using the Health Utilities Index Step 3 (Adolescent and Parent)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • American Diabetes Association

Registry information

Acronym: TeensConnect

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 4, 2013
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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